Medicines savings and Health Insurance Act changes in 2017

Lääketeollisuus ry

Finland will impose a 10% cut in the medicines reimbursement expenditure as of the beginning of 2017. The cuts will amount to 134 million euros,  constituting one element in the overall savings in public spending, targeted at core areas of the society.

From the perspective of the pharmaceutical industry and the entire reimbursement system, the savings are huge. They are complementary to the medicines reimbursements savings already made in the beginning of the current year.

Through comprehensive preparation to where we are now

The Ministry of Social Affairs and Health prepared the savings in collaboration with the pharmaceutical branch stakeholders. The objective of Pharma Industry Finland PIF was to try to implement the savings in a way that would not significantly weaken the pharmaceutical industry’s possibilities to develop novel medicines.

The preparation work done on a comprehensive basis helped to identify means that are going to be more balanced for the patients, the society and the pharmaceutical branch actors than they have been in the past. One such means is the promotion of rational pharmacotherapies.

Savings measures and their impacts on PIF member companies

The main proposed savings measures impacting the industry included the strengthening of price competition between the pharmaceutical companies, the promotion of rational pharmacotherapies and the introduction of a risk sharing procedure.

PIF finds that the mechanisms promoting the price competition within the generic reference price system are a positive option. In fact, the competition mechanisms within the Finnish reference price system do not operate optimally, and the prices of generics took a clear upward turn in 2011.

Biological products are now also subject to the means to enhance competition. Physicians are encouraged to use the most inexpensive product if there is a biosimilar available for the original biological medicine.  Substitution at the pharmacy will not be introduced. The first reimbursable biosimilar will be covered by a new price rule whereby the price level is maximum 70% of the adopted list price of the innovative medicine. Once the biosimilar is launched, the list price of the innovative medicine will be re-examined.

PIF is opposed to the proposal of a reference group constitution initiated by the parallel import and parallel distribution products. According to the proposal, the launching of a parallel import product could constitute a reference price group whereas to date, the forming of a group has been possible only if it includes a generic medicine. The reform seeks to increase the use of parallel import products, thus also enhancing the price competition of medicines. PIF fears that the reform will have a significant negative effect on the predictability of the operations of the member companies in Finland. Moreover, the proposal would bring about major medicine availability risks.

The measures promoting rational pharmacotherapies seek to diminish the unnecessary use of medicines and to reduce pharmaceutical waste. The means to this end include, among others, favouring smaller package sizes and limiting the dispensing of very expensive medicines so that the pharmacy would only dispense the dosage for one month instead of the normal three-month need. As regards the dispensing intervals of medicines in the basic reimbursement category, a stricter time control is proposed.

Finland will introduce an experimental risk-sharing procedure

Along with the other changes, the introduction of an experimental risk-sharing procedure is proposed. It will open possibility for an adaptive reimbursement for new products  The aim of the procedure is to create new ways to manage the uncertainty related to novel products, thereby accelerating their access to patients.

The introduction of the risk-sharing agreements would support the Finnish innovation policy and the objectives of the life-science growth strategy of 2014. At the initial stage, the procedure will be experimental. The process needs to be further developed by the Pricing Board in collaboration with the applicants. In the initial phase, only few products can be included in it. If the three year experimental period proves to be successful, the legislative changes to confirm the procedure it will be made.  PIF is working in close collaboration with the Ministry and companies to create necessary MO’s for the procedure.